Postoperative Complications Clinical Trial
Official title:
Perianal Maceration in Pediatric Ostomy Closure Patients
Verified date | May 2021 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot study will explore whether preoperative application of stool from the stoma bag to the perianal area will prevent/ decrease postoperative perianal maceration in pediatric ostomy closure patients. It will also explore the overall safety and feasibility of this pilot study for larger randomized control trials. There will be a control group and an intervention group. The intervention group will apply stool from the stoma bag approximately 4 weeks prior to ostomy closure and fill out a compliance log and upload pictures weekly to the MyCHP (My Children's Hospital) portal. A validated diaper dermatitis score will be utilized in this study.
Status | Completed |
Enrollment | 7 |
Est. completion date | May 7, 2021 |
Est. primary completion date | May 7, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 3 Years |
Eligibility | Inclusion Criteria: - Ostomy closure (colostomy & ileostomy) - ages 3 years & under (still in diapers) - male & female - Scheduled ostomy closure in approximately 4 weeks. - The legal guardian/parent of subject must have a personal device, such as a cell phone, that has access to internet in order to sign on to the MyCHP Portal. - Participants must be enrolled in the MyCHP Portal. Exclusion Criteria: - Patients with a history of hypersensitive skin - dermatological diagnosis - ostomies other than colostomies/ileostomies - ages older than 3 years - Subjects who are not enrolled in the MyCHP Portal. - Subjects with parents who do not have a personal device, such as a cell phone, or access to internet. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | Robert Morris University |
United States,
Babuna Kobaner G, Sun GP, Ozkaya E. A recalcitrant case of Jacquet erosive diaper dermatitis after surgery for Hirschsprung disease in a boy with Waardenburg-Shah syndrome. Dermatol Online J. 2018 Jun 15;24(6). pii: 13030/qt8fk4t4rm. — View Citation
Dasgupta R, Langer JC. Evaluation and management of persistent problems after surgery for Hirschsprung disease in a child. J Pediatr Gastroenterol Nutr. 2008 Jan;46(1):13-9. Review. — View Citation
Gray M. Incontinence-related skin damage: essential knowledge. Ostomy Wound Manage. 2007 Dec;53(12):28-32. Review. — View Citation
Heimall LM, Storey B, Stellar JJ, Davis KF. Beginning at the bottom: evidence-based care of diaper dermatitis. MCN Am J Matern Child Nurs. 2012 Jan-Feb;37(1):10-6. doi: 10.1097/NMC.0b013e31823850ea. — View Citation
Keller DS, Khorgami Z, Swendseid B, Khan S, Delaney CP. Identifying causes for high readmission rates after stoma reversal. Surg Endosc. 2014 Apr;28(4):1263-8. doi: 10.1007/s00464-013-3320-x. Epub 2013 Nov 27. — View Citation
Lim YSL, Carville K. Prevention and Management of Incontinence-Associated Dermatitis in the Pediatric Population: An Integrative Review. J Wound Ostomy Continence Nurs. 2019 Jan/Feb;46(1):30-37. doi: 10.1097/WON.0000000000000490. Review. — View Citation
Rodriguez-Poblador J, González-Castro U, Herranz-Martínez S, Luelmo-Aguilar J. Jacquet erosive diaper dermatitis after surgery for Hirschsprung disease. Pediatr Dermatol. 1998 Jan-Feb;15(1):46-7. — View Citation
Shin HT. Diaper dermatitis that does not quit. Dermatol Ther. 2005 Mar-Apr;18(2):124-35. Review. — View Citation
Tamaki K, Yokomori K. Diaper dermatitis with granuloma following surgery for Hirschsprung's disease. J Dermatol. 1987 Jun;14(3):262-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perianal skin maceration in the group receiving the intervention vs. the control group | this will be measured by uploading pictures or visual inspections and utilizing a validated diaper dermatitis scale (total severity score for the scale is 0-6, a higher score (6) indicates a worse outcome) | from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery) | |
Secondary | The number & identification of influencing characteristics/variables of perianal skin breakdown | This will be done by doing a retrospective chart review and by reviewing the compliance log and parent questionnaire. The compliance log & parent questionnaire will be asking diaper brand, diet, stool consistency, etc. This will be determined by statistical analysis and by looking at diaper dermatitis scores via the validated scale (total severity score for the scale is 0-6, a higher score (6) indicates a worse outcome) | from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery) | |
Secondary | Incidence of complications (safety and tolerability of intervention) from application of stool between ileostomies vs. colostomies | this will be measured by uploading pictures or visual inspections and utilizing a validated diaper dermatitis scale (total severity score for the scale is 0-6, a higher score (6) indicates a worse outcome) | from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery) | |
Secondary | Explore parent compliance of application of stool at home vs. staff (RN) compliance of application of stool when inpatient | This will be done by reviewing the preoperative compliance log. The compliance log has a section to record when the application was performed and by who. (Should be twice daily 4 weeks prior to ostomy closure). | from enrollment to the follow up postoperative appointment (approximately 4 weeks after surgery) |
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